Feel free to download the slide deck of one of our recent talks on the new Medical Device Regulation which was presented by Jan Bart Hak at the autumn meeting of the Pharmacovigilance Platform Netherlands on November 21st, 2017.
The European Medical Device Regulation 2017/745 (MDR) is published on May 5, 2017, in order to replace the current Medical Device Directive 93/42; it will apply 3 years after this date. Requirements related to the technical file and procedures will be significantly reinforced, without the possibility of grandfathering.
These new requirements will affect the entire medical device (MD) industry with products in the EU. This implies that companies with products on the market within the European Union will need to come up with a transition plan to comply with these new rules and they have until May 25th, 2020 to do so.
A short calculation tells us that the countdown is at two and a half years at this point. As an example, in case the clinical evidence needs to be updated, one must start now. Clinical evidence can be collected in a clinical investigation or via post-marketing surveillance, which includes vigilance and post-marketing clinical follow-up studies. If a medical device company does not start now, it can be too late risking the CE mark and so market access.